At Celerion, we support oncology drug development in three ways: pharmacokinetic and safety studies in healthy subjects when scientifically and medically justified; biomarker assays to assess effects on tumors and immune response; and traditional clinical project management and clinical monitoring of multi-center studies in patients for a broad range of cancers.
Celerion has conducted over 100 studies in our confined clinics in healthy subjects for drugs that target cancer. These include single dose and multiple dose studies to examine safety, pharmacokinetics, ADME and potential drug-drug interactions in a highly-controlled clinical research setting. Such studies are permitted by regulators and ethics committees if the drug candidate is highly targeted to tumor cells with no impact on normal cells as demonstrated by thorough preclinical assessment of safety and mechanism of action. When possible, highly informative data can be produced efficiently to quickly advance a clinical program and provide more informed dosing decisions for patients.
Biomarkers of drug effect and immune response are critical elements of early clinical research, particularly for immuno-oncology therapeutic approaches. Celerion’s bioanalytical scientists are experts at leveraging state-of-the-art technologies such as ELISA, MSD and cell-based assays for measuring antibody titers, cytokines, chemokines and other biomarkers as well as flow cytometry, ELispot and qPCR to characterize immuno-cellular and tumor response to new therapies.
Celerion has successfully supported multi-site, multi-country oncology studies covering over 25 indications within this complex therapeutic area. We provide access to key investigators, experienced study centers, networks of specialized labs (CTC/DTC/PBMC), insightful study design and highly skilled project teams. Celerion has designed and conducted programs in the rapidly expanding area of immuno-oncology in indications such as NSCLC, prostate cancer, ovarian cancer and colorectal carcinoma, to name a few.
More than any other therapeutic area, oncology products follow an unconventional path to registration. For many, combination Phase I/II or II/III studies will be a part of this plan. Celerion has significant experience in assisting clients with novel and adaptive design study protocols. By combining comprehensive laboratory services, complex sample size determination, PK/PD modeling, DSMB set-up and clinical study conduct, Celerion can provide a turnkey solution to these novel programs.
Celerion Bioanalytical Support of Oncology Studies
Scientific Expertise, Fast Turnaround Time & Flexibility
